MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 FLOPPY 205CM; WIRE, GUIDE, CATHETER

Catalog Number	M001468070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure the subject guidewire tip detached inside the catheter during removal from the patient.The device was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.H3 summary attached - updated.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection the subject guidewire tip was noted to be broken/fractured 197cm from the proximal end (approx.10cm distal section detached).The surface of the break was rough.The guidewire tip was noted to be kinked/bent approximately 1.5cm from the distal end.A functional inspection could not be performed due to the damage to the guidewire.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated the distal 10cm of the wire detached during removal of the guidewire from the catheter.The issue of guidewire tip fractured occurred inside the patient.Product analysis found the guidewire tip was broken/fractured 197cm from the proximal end (approx.10cm distal section detached) and the guidewire tip was kinked/bent approximately 1.5cm from the distal end.The condition of the returned guidewire suggests that excessive torque and manipulation was applied to the device during the procedure which resulted in the observed damage.An assignable cause of procedural factors will be assigned to the reported and analyzed event of the guidewire distal tip broken/fractured during use and in addition to the as analyzed damage of the guidewire distal end/tip kinked/bent as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported during the procedure the subject guidewire tip detached inside the catheter during removal from the patient.The device was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.

• Brand Name: TRANSEND EX 14 FLOPPY 205CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer (Section G): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18768968
• Report Number: 3008853977-2024-00007
• Device Sequence Number: 4462105
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K944677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2024
• Device Catalogue Number: M001468070
• Device Lot Number: 30753466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER (UNKNOWN); TARGET COILS (STRYKER)
• Patient Age: 61 YR
• Patient Sex: Female